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Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

US

Last updated May 23, 2026

What Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. makes

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. manufactures patient monitoring devices, including the Passport Series monitors (such as the Passport 17M and Passport 12M), the VS 8, VS 8A, and VS 9 vital signs monitors, as well as the Accutorr 7 and VS-900. Their portfolio also includes the ViewMate multi-ultrasound system and the Resona 7 series diagnostic ultrasound systems (Resona 7, 7CV, 7EXP, 7S, and 7OB). The company produces central monitoring systems, such as the Hypervisor, including the TMS-6016 telemetry monitoring system.

These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) clearance registry. The company operates with a US presence, though its headquarters are based in Shenzhen, China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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US
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Catalogue (1079)

Page 10 of 22
DeviceModel / ReferenceRegistriesClassStatus
L7-3s Ultrasonic Probe Konica(FDA) 120-004751-00
FDA UDI
Class IIActive
Movement Sensor Holder Package 115-042850-00
FDA UDI
Class IIActive
E9-3 Endocavitary Tranducer 87444-00 Z139-00
FDA UDI
Class IIActive
Manual rerun rack assembly 801-BA80-00257-00
FDA UDI
Class IIActive
Magnetic Transmitter Trolley Kit(CE/FDA) 115-041416-00
FDA UDI
Class IIActive
GCX M series 12"pivot arm with adapter A 045-003427-00
FDA UDI
Class IIActive
Temperature adapter cable(2Pin plug) 040-001235-00
FDA UDI
Class IIActive
Calibrator rack assembly 801-BA80-00255-00
FDA UDI
Class IIActive
1-Slot CO2/O2 Module w/ kit (Neo) 115-053712-00
FDA UDI
Class IIActive
TEL-100 waterproof case(5lead IEC SNAP) 115-010670-00
FDA UDI
Class IIActive
IBP Adapter Cable 040-000096-00
FDA UDI
Class IIActive
SP5-1s Ultrasonic Transducer(SMS) 120-005510-00
FDA UDI
Class IIActive
NGB-005 Needle-guided Bracket/VET 115-001753-00
FDA UDI
Class IIActive
ECG Module(ANA lead/FDA) 115-003490-00
FDA UDI
Class IIActive
SPO2 Module (Mindray/Package/ accessory) 115-047245-00
FDA UDI
Class IIActive
Sevoflurane Quik Filler Vaporizer(FDA) 115-025532-00
FDA UDI
Class IIActive
L14-6N Ultrasonic Probe(FDA) 120-001126-01
FDA UDI
Class IIActive
Li-ion Bat Pack (11.1V4500mAh LI23S002A) 115-018012-00
FDA UDI
Class IIActive
ECG Module Kit(2145/AHA) 115-051244-00
FDA UDI
Class IIActive
IBP_CO module(FDA/FJ/PK.) 115-030781-00
FDA UDI
Class IIActive
Leadst, 5lead, Ext, Pnch, 24", Aami 0012-00-1820-02
FDA UDI
Class IIActive
Wall Mount TCN17-GG001-F-012
FDA UDI
Class IIActive
AGSS 3 ways connector assembly 115-026796-00
FDA UDI
Class IIActive
L11-3U Ultrasonic Probe(FDA) 120-003563-00
FDA UDI
Class IIActive
VCR connect wire kit 115-004163-00
FDA UDI
Class IIActive
P8-2s Transducer(FDA-SJM) 120-023005-00
FDA UDI
Class IIActive
Eagus TEX20 Diagnostic Ultrasound System Eagus TEX20
FDA UDI
Class IIActive
Datascope Adult Long Color-coded S1-0683-15-0006-01
FDA UDI
Class IIActive
Bladderless Large Adult Cuff(CM1304 MW) 115-027716-00
FDA UDI
Class IIActive
SC5-1U Sensor Holder Package 115-042845-00
FDA UDI
Class IIActive
BC-6D Hematology Control BC-6D
FDA UDI
Class IIActive
NGB-035 Needle-guided Bracket 120-005596-00
FDA UDI
Class IIActive
CCO/SvO2 Module w/ cable 115-053718-00
FDA UDI
Class IIActive
Physio & Pen Probe Port(AHA) 115-048403-00
FDA UDI
Class IIActive
P7-3c Phased Array Tranducer 89100-00 P7-3c
FDA UDI
Class IIActive
Patient Monitor Passport 12m Passport 12m
FDA UDI
Class IIActive
65EB10EA Ultrasonic Transducer(FDA) 120-001147-00
FDA UDI
Class IIActive
NGB-004 Needle-guided Bracket/VET 120-001451-00
FDA UDI
Class IIActive
NGB-006 Needle-guided Bracket/PLAS/VET 120-002155-00
FDA UDI
Class IIActive
ORIDION CO2 mod upgrd kit, intl 115-046966-00
FDA UDI
Class IIActive
2P2s Ultrasonic Transducer(FDA) PP3A-30-90858
FDA UDI
Class IIActive
SP5-1s Ultrasonic Transducer(FDA) 120-002703-00
FDA UDI
Class IIActive
3-Lead, ECG, Univ, Pinch, 18", IEC 0012-00-1514-13
FDA UDI
Class IIActive
BeneVision Central Monitoring System BeneVision
FDA UDI
Class IIActive
uMEC15S Patient Monitor uMEC15S
EUDAMEDFDA UDI
Class IIActive
E9-3 Endocavitary Tranducer 87444-30 Z139-30
FDA UDI
Class IIActive
Telemetry Transmitter 608M
FDA UDI
Class IIActive
Li-ion Bat Pack (11.1V4800mAh LI23I002A) 115-018013-00
FDA UDI
Class IIUnknown
B/W video printer(FDA) 115-032023-00
FDA UDI
Class IIActive
ORIDION CO2(Package/no accessory) 115-046928-00
FDA UDI
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Shenzhen Mindray Bio-Medical Electronics Co., LTD SHENZHEN Guangdong · CN FEI 3007603826